Oral Nutritional Supplement in Reducing Surgical Site Infections

Peripheral Vascular Disease Clinical Trial

Official title:

The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02475525
• Other study ID #: ONS2015
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: May 2018
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement in the prevention of wound complications in the the wounds of patients post lower limb revascularization.

Description:

Surgical incisions are associated with a number of possible complications. The reported incidence of surgical site infections at the groin after vascular procedures is between 3% and 30%. This incidence is up to five times higher than the expected incidence of infection in clean cases. Risk factors for postoperative surgical site infection in patients undergoing vascular surgery may include age, co-morbidities, use of prosthetic grafts and repeat operations.

A systematic review in 2011 concluded that arginine supplemented diets among perioperative patients were associated with a reduced rate of surgical infection and reduced overall length of hospital stay.

The study aims are to determine if taking an oral nutritional supplement reduces the rate of wound complications post lower limb revascularization.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 1, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for elective lower limb revascularization surgery

• patients aged >18 years.

Exclusion Criteria:

• Patients unable to provide informed consent,

• emergency cases,

• seriously ill patients/unconscious patients,

• chronic renal disease,

• known inflammatory bowel disease,

• known lactose intolerance and not using lactase,

• known galactosemia,

• pregnancy,

• cows milk allergy.

Related Conditions & MeSH terms

• Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Dietary Supplement:
• Arginine enriched oral nutritional supplement
oral nutritional supplement containing arginine

Locations

Country	Name	City	State
Ireland	University Hospital Limerick	Limerick

Sponsors (2)

Lead Sponsor	Collaborator
University of Limerick	UL Hospitals, Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.		4 weeks
Secondary	Patient acceptability of the oral nutritional supplement.		4 weeks
Secondary	Duration of post operative hospital stay		4 weeks